Oncology Clinical Research Coordinator – NIH/NCI Trials

Axle Info; Bethesda (MD); Presencial; USD 145.000 - 155.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Paid Time Off and Holidays

401K match up to 5%

Educational Benefits for Career Growth

Employee Referral Bonus

Flexible Spending Accounts: Healthcare

Parking Reimbursement Account

Dependent Care Assistant Program

Transportation Reimbursement Account

Descripción de la vacante

Axle Info is seeking a Clinical Research Coordinator to support NIH/NCI cancer trials in Bethesda, MD. You will coordinate studies through startup to closeout, enroll and follow participants, manage data, and ensure protocol compliance.

The role involves regulatory submissions, source documentation, and collaboration with investigators. A nursing or biological/health sciences background is required, with oncology trial experience preferred.

Formación

• Bachelor’s degree in nursing, biological sciences, public health, health sciences, clinical research, or a related field.
• Experience supporting oncology clinical trials and clinical research operations.
• Demonstrated experience supporting clinical trials from startup through closeout.
• Knowledge of FDA regulations, ICH-GCP, human subjects protections, and clinical trial methodology.
• Experience with EMR, CTMS, and EDC platforms.
• Strong organizational, communication, and project coordination skills.
• Provide monthly enrollment and accrual reports, regulatory tracking reports, and data quality reports.

Responsabilidades

• Coordinate multiple clinical studies from startup through closeout with investigators and teams.
• Screen, recruit, assess eligibility, and schedule participants per protocol; support informed consent.
• Serve as primary contact for participants; explain procedures and monitoring adherence.
• Coordinate visits, procedures, labs, imaging, and ancillary services within visit windows.
• Coordinate PK/PD, biomarker, QoL, and PRO assessments including questionnaires.
• Collaborate with staff on blood specimens, ECGs, vital signs, and wearable data.
• Maintain source documentation, EMR entries, and regulatory records; review outside records.
• Coordinate specimen collection, processing, storage, and shipment; maintain chain-of-custody.
• Enter data, verify CRFs, resolve queries, and perform quality control with data management.
• Maintain databases, trackers, study metrics, and prepare enrollment/workload reports.

Conocimientos

Oncology trial experience

Clinical research operations

Regulatory knowledge (FDA/ICH-GCP)

EMR/CTMS/EDC familiarity

Organizational and coordination skills

Data quality and reporting

Educación

Bachelor’s degree in nursing or biological/health sciences

Herramientas

Electronic medical records

Clinical trial management systems

Electronic data capture platforms

Descripción del empleo

Axle Info is seeking a Clinical Research Coordinator to support NIH/NCI cancer trials in Bethesda, MD. You will coordinate studies through startup to closeout, enroll and follow participants, manage data, and ensure protocol compliance.

The role involves regulatory submissions, source documentation, and collaboration with investigators. A nursing or biological/health sciences background is required, with oncology trial experience preferred.